ISO 80601-2-12:2020

Title
Abstract

This document applies to the basic safety and essential performance of a ventilator in combination with its accessories, hereafter referred to as ME equipment:

  • intended for use in an environment that provides specialized care for patients whose conditions can be life-threatening and who can require comprehensive care and constant monitoring in a professional healthcare facility;

NOTE 1 For the purposes of this document, such an environment is referred to as a critical care environment. Ventilators for this environment are considered life-sustaining.

NOTE 2 For the purposes of this document, such a ventilator can provide transport within a professional healthcare facility (i.e. be a transit-operable ventilator).

NOTE 3 A critical care ventilator intended for use in transport within a professional healthcare facility is not considered as an emergency medical services environment ventilator.

  • intended to be operated by a healthcare professional operator; and
  • intended for those patients who need differing levels of support from artificial ventilation including for ventilator-dependent patients.

A critical care ventilator is not considered to utilize a physiologic closed-loop-control system unless it uses a physiological patient variable to adjust the ventilation therapy settings.

This document is also applicable to those accessories intended by their manufacturer to be connected to a ventilator breathing system, or to a ventilator, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilator.

NOTE 4 If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant.

Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in IEC 60601-1:2005, 7.2.13 and 8.4.1.

NOTE 5 Additional information can be found in IEC 60601-1:2005+AMD1:2012, 4.2.

This document is not applicable to ME equipment or an ME system operating in a ventilator-operational mode solely intended for patients who are not dependent on artificial ventilation.

NOTE 6 A critical care ventilator, when operating in such a ventilator-operational mode, is not considered life-sustaining.

This document is not applicable to ME equipment that is intended solely to augment the ventilation of spontaneously breathing patients within a professional healthcare facility.

This document does not specify the requirements for:

  • ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601-2-13[2];
  • ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601-2-84[3], the future replacement for ISO 10651-3[4];
  • ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601‑2-72:2015[5];
  • ventilators or accessories intended for home-care ventilatory support devices, which are given in ISO 80601-2-79:2018[6] and ISO 80601-2-80:2018[7][1];
  • obstructive sleep apnoea therapy ME equipment, which are given in ISO 80601‑2‑70[9];
  • continuous positive airway pressure (CPAP) ME equipment;
  • high-frequency jet ventilators (HFJVs) and high-frequency oscillatory ventilators (HFOVs), which are given in ISO 80601‑2‑87[63];

NOTE 7 A critical care ventilator can incorporate high-frequency jet or high-frequency oscillatory ventilator-operational modes.

  • oxygen therapy constant flow ME equipment; and
  • cuirass or "iron-lung" ventilation equipment.

[1] ISO 80601-2-79 and ISO 80601-2-80 replace ISO 10651-6, which has been withdrawn.

Issue Date

2020-02-25

Category

MED

Included in IECEE System

2020-07-29

Purchase webstore
Test Report Form
Testing Equipment List

No information declared

DISCLAIMER: National differences

The National differences and Group differences, National Deviations and Special National conditions (SNC), are based solely on information provided to the Secretariat by the IECEE Member Bodies and/or NCBs and other sources. The IEC/IECEE is not responsible for, nor will it take any position related to, the accuracy or validity of the information provided. To verify the current status of this type of information, we recommend contacting the Member Body (MB) or National Certification Body (NCB) of the relevant country.

Group Differences are applicable for CENELEC member countries: Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.

Group/Country

Reference

Last Modified

Differences

TRF Addendum

CanadaCanada

2021-11-10

Download55 kb

DenmarkDenmark

2021-02-01

Download14 kb

Laboratory Name

City

Country

Responsible National Certification Body

Suwon-si

Korea, Republic of

Littleton 01460

United States of America

Wismar

Germany

94342 Strasskirchen

Germany

Toronto

Canada

Irvine

United States of America

Fehraltorf

Switzerland

Modiin

Israel

Boxborough,

United States of America

Lake Forest,

United States of America

Kista

Sweden

Fontenay-Aux-Roses

France

Carlsbad,

United States of America

Gyeonggi-do

Korea, Republic of

Lysaker

Norway

Munich

Germany

Shanghai

China

Guangzhou

China

Tel-Aviv

Israel

Budapest

Hungary

Nürnberg

Germany

San Diego

United States of America

Guangzhou 510656

China

Singapore 609937

Singapore

München

Germany

Ballerup

Denmark

Suzhou

China

Offenbach / Main

Germany

Id

Name

City

Country

13336

Toronto, Ontario

Canada

13372

Fehraltorf

Switzerland

20269

Modiin

Israel

13371

Kista

Sweden

13424

IL 60005

United States of America

13343

Fontenay-Aux-Roses

France

13361

Lysaker

Norway

13334

BRUSSELS 1070

Belgium

13342

Helsinki

Finland

13597

Tel-Aviv

Israel

13349

Budapest

Hungary

13345

Nürnberg

Germany

13427

Singapore 609937

Singapore

13346

München

Germany

13340

Ballerup

Denmark

13344

Offenbach / Main

Germany

Id

Name

City

Country

13607

Baltimore,

United States of America

13469

Toronto,

Canada